Peritoneal Dialysis Complication Clinical Trial
— Fluid-PLUSOfficial title:
Assessing Fluid Status of Peritoneal Dialysis Patients With Assistance of Lung Ultrasound
Verified date | November 2019 |
Source | Satellite Healthcare |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
- As studied previously, lung congestion is very prevalent however usually asymptomatic in
dialysis patients. Fluid overload is associated with hospitalizations, worse
cardiovascular outcomes and mortality in PD patients.
- The clinical exam is the only tool used currently to monitor volume status of PD
patients, and has been found to have poor sensitivity and specificity for lung
congestion compared to lung ultrasound. In current practice, patients are seen and
examined monthly at their home dialysis units by the nurses. The nephrologist separately
examines the patient monthly, possibly days to weeks after the nurse visit, and
potentially only quarterly with the use of telehealth visits.
- Lung ultrasound is a relatively simple and cheap tool to assess for lung congestion,
with little inter-operator variability and good reproducibility.
- There are limited studies of lung ultrasound in peritoneal dialysis, and none in the
United States. Lung ultrasound may be useful as an objective measure of lung congestion
in patients without signs or symptoms of fluid overload.
Aims of this study
- This study aims to determine the prevalence of subclinical fluid overload in peritoneal
dialysis patients.
- The investigators aim to determine the added benefit of lung ultrasound to standard
clinical practice of fluid management in PD patients.
- The investigators aim to assess the association of patient characteristics with lung
congestion.
- The investigators also aim to assess the agreement between nurse physical exam and lung
ultrasound for fluid overload.
Status | Completed |
Enrollment | 44 |
Est. completion date | June 30, 2020 |
Est. primary completion date | April 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Peritoneal dialysis patients seen at participating Wellbound clinics in Northern California, present for monthly visit on days in which lung ultrasound available Exclusion Criteria: - Age <18, on peritoneal dialysis <3 mo, symptomatic lung congestion (reporting new or worsening shortness of breath over the past 4 weeks on enrollment), patient or nephrologist unwilling to participate in study |
Country | Name | City | State |
---|---|---|---|
United States | WellBound Daly City | Daly City | California |
United States | Satellite WellBound Emeryville | Emeryville | California |
United States | Satellite WellBound Fremont | Fremont | California |
United States | Satellite WellBound Milpitas | Milpitas | California |
United States | WellBound Modesto | Modesto | California |
United States | WellBound North Modesto | Modesto | California |
United States | Satellite WellBound Mountain View | Mountain View | California |
United States | WellBound Sacramento | Sacramento | California |
United States | WellBound San Francisco | San Francisco | California |
United States | Satellite WellBound San Jose | San Jose | California |
United States | WellBound San Leandro | San Leandro | California |
United States | Satellite WellBound San Mateo | San Mateo | California |
United States | Wellbound Santa Cruz | Santa Cruz | California |
United States | WellBound Santa Rosa | Santa Rosa | California |
United States | WellBound Stockton | Stockton | California |
United States | WellBound Vallejo | Vallejo | California |
Lead Sponsor | Collaborator |
---|---|
Satellite Healthcare |
United States,
Gargani L, Sicari R, Raciti M, Serasini L, Passera M, Torino C, Letachowicz K, Ekart R, Fliser D, Covic A, Balafa O, Stavroulopoulos A, Massy ZA, Fiaccadori E, Caiazza A, Bachelet T, Slotki I, Shavit L, Martinez-Castelao A, Coudert-Krier MJ, Rossignol P, — View Citation
Panuccio V, Enia G, Tripepi R, Torino C, Garozzo M, Battaglia GG, Marcantoni C, Infantone L, Giordano G, De Giorgi ML, Lupia M, Bruzzese V, Zoccali C. Chest ultrasound and hidden lung congestion in peritoneal dialysis patients. Nephrol Dial Transplant. 20 — View Citation
Torino C, Gargani L, Sicari R, Letachowicz K, Ekart R, Fliser D, Covic A, Siamopoulos K, Stavroulopoulos A, Massy ZA, Fiaccadori E, Caiazza A, Bachelet T, Slotki I, Martinez-Castelao A, Coudert-Krier MJ, Rossignol P, Gueler F, Hannedouche T, Panichi V, Wi — View Citation
Zoccali C, Torino C, Tripepi R, Tripepi G, D'Arrigo G, Postorino M, Gargani L, Sicari R, Picano E, Mallamaci F; Lung US in CKD Working Group. Pulmonary congestion predicts cardiac events and mortality in ESRD. J Am Soc Nephrol. 2013 Mar;24(4):639-46. doi: — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of subclinical fluid overload in peritoneal dialysis patients | percentage of patients with moderate-severe lung congestion on ultrasound and nurse physical exam without fluid overload | single monthly nurse visit | |
Secondary | Added benefit of lung ultrasound to standard clinical practice of fluid management in PD patients | percentage of patients with subclinical fluid overload who have a change in PD prescription or diuretics | single monthly nurse visit | |
Secondary | Association of patient characteristics with lung congestion | Odds ratios for lung congestion from subgroup analyses and logistic regression | single monthly nurse visit | |
Secondary | Agreement between nurse physical exam and lung ultrasound for fluid overload | kappa coefficient between lung ultrasound and nurse exam for fluid overload | single monthly nurse visit |
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